Instructions for use Ulcavis film-coated tablets 120 mg blister No. 112
Composition
active ingredient: bismuth subcitrate;
1 tablet contains 120 mg of bismuth oxide in the form of bismuth tripotassium dicitrate (bismuth subcitrate);
excipients: corn starch, povidone K-30, polacrilin potassium, macrogol 6000, magnesium stearate;
film coating: Opadry II transparent (contains: polyvinyl alcohol, macrogol 4000, talc), titanium dioxide (E 171).
Dosage form
Film-coated tablets.
Main physicochemical properties: white to off-white, round, slightly biconvex, film-coated tablets with a beveled edge.
Pharmacotherapeutic group
Drugs for the treatment of peptic ulcer and gastroesophageal reflux disease. Bismuth subcitrate. ATC code A02B X05.
Pharmacological properties
Pharmacodynamics
In the acidic environment of the stomach, the drug forms a protective film on the surface of ulcers and erosions, which promotes their scarring and protects against the effects of gastric juice; increases the synthesis of prostaglandin E2, stimulates the formation of mucus and bicarbonates, promotes the accumulation of epidermal growth factor in the defect zone, reduces the activity of pepsin and pepsinogen. The drug has bactericidal activity against Helicobacter pylori.
Pharmacokinetics
The drug is practically not absorbed from the gastrointestinal tract; only a small amount of the active substance enters the blood and is excreted in the urine, while the concentration of bismuth in the plasma decreases rapidly after the end of treatment. It is excreted mainly with feces.
Indication
Gastric and duodenal ulcers, including those caused by Helicobacter pylori (as part of anti-Helicobacter therapy regimens); chronic gastritis and gastroduodenitis in the exacerbation phase, including those caused by Helicobacter pylori.
Contraindication
Hypersensitivity to the active substance or to any of the excipients. Severe renal failure.
Interaction with other medicinal products and other types of interactions
No other medicines, food or drinks, antacids, milk, fruit or fruit juices should be consumed within half an hour before and after taking Ulcavis®, as they may alter its effect.
A decrease in the absorption of tetracyclines is theoretically possible when used simultaneously with Ulcavis®.
Concomitant use of bismuth-containing drugs increases the risk of excessive increase in bismuth concentration in the blood.
Application features
The stool may turn black - in this case, you should consult a doctor. You should not take antacids and drink milk half an hour before and within half an hour after taking the drug, since the existing gastric juice is needed to form a protective layer.
Long-term use of bismuth compounds is not recommended due to the occurrence of encephalopathy in rare cases. If the recommended dosage regimen is followed, the risk of this side effect is very small, however, it is not recommended to take other bismuth-containing drugs while taking this drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of the drug on the ability to drive vehicles or other mechanisms. However, such an effect of Ulcavis® is unlikely.
Use during pregnancy or breastfeeding
Due to insufficient data, use during pregnancy or breastfeeding is not recommended.
Method of administration and doses
Adults and children over 14 years of age should take 1 tablet 4 times a day or 2 tablets 2 times a day 30 minutes before meals and at night.
Children aged 8 to 14 years should take 1 tablet 2 times a day 30 minutes before meals.
Children aged 4 to 8 years should be prescribed a dose of 8 mg/kg/day, according to body weight:
Children weighing 15 kg to 30 kg should take 1 tablet per day 30 minutes before meals. Children weighing more than 30 kg should take 1 tablet 2 times a day 30 minutes before meals.
The tablets should be swallowed whole with a small amount of water. The duration of the treatment course is 4–8 weeks. For at least the next 2 months, you should not take medications containing bismuth.
In the presence of Helicobacter pylori, use the following in treatment regimens:
In quadruple therapy, a combination of Ulcavis®, 120 mg tablets 4 times a day, with tetracycline 500 mg 4 times a day, metronidazole 500 mg 3 times a day, and a proton pump inhibitor (omeprazole, lansoprazole, rabeprazole, pantoprazole, or esomeprazole) in a standard therapeutic dose 2 times a day is recommended.
The duration of combination therapy is 10–14 days.
To improve the regeneration of the ulcer defect, further treatment with Ulcavis® is possible: 1 tablet 4 times a day - 30 minutes before breakfast, lunch, dinner and before bedtime. The total duration of therapy with Ulcavis® is up to 6 weeks (maximum - 8 weeks).
Children
Ulcavis® can be used in children aged 4 years and older.
Overdose
Occurs in the case of frequent administration of large doses of the drug and may manifest after 10 days with symptoms characteristic of renal failure (increased levels of bismuth in blood plasma).
In case of impaired kidney function, accompanied by a high content of bismuth in the blood plasma, complexing compounds are used - dimercaptosuccinic and dimercaptopropanesulfonic acids.
Treatment consists of gastric lavage followed by the use of activated charcoal and osmotic laxatives. Bismuth absorption as an additional treatment is not required. In case of concomitant severe kidney diseases, hemodialysis should be performed.
Adverse reactions
Very common (> 10%)
On the part of the digestive tract: black stools.
Uncommon (> 0.1%, < 1%)
On the part of the digestive tract: nausea, vomiting, constipation, diarrhea.
Skin and subcutaneous tissue disorders: rash, itching.
Frequency unknown:
Immune system disorders: anaphylactic reaction.
Expiration date
3 years.
Storage conditions
Store in the original packaging to protect from moisture and light.
Keep out of reach of children.
Packaging
14 tablets in a blister; 8 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
KRKA, dd, Novo mesto, Slovenia.
Location of the manufacturer and its business address
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
